Nocturnal Insulin-Glucose in Hospital: Tight Control

Type 1 Diabetes Clinical Trial

— NIGHT CONTROL  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02160184
• Other study ID #: NIGHT CONTROL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 9, 2014
• Last updated: June 9, 2014

Study information

• Verified date: June 2014
• Source: Corporacion Parc Tauli
• Contact: Mercedes Rigla, MD, PhD
• Phone: +34 93 745 84 12
• Email: mrigla[@]tauli.cat
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to assess the efficacy and safety of a closed-loop system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS) in patients with type 1 diabetes for controlling the nocturnal and post-breakfast periods. Intervention will be to apply the automated closed-loop system by administering a subcutaneous insulin microbolus every 5 minutes depending on reading from a continuous glucose measurement (CGM) system.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Type 1 Diabetes

• Diabetes duration > 3 years

• Continuous Subcutaneous Insulin Infusion (CSII) treatment for more than 1 year

• A1c 6-9%

• No ketoacidosis during the previous 12 months

• Glomerular Filtration Rate (GFR) > 60 ml/kg/min m2

• Willingness of participate and signed and dated written informed consent in accordance with Good Clinical Practice

Exclusion Criteria:

• Gastroparesis

• Hypoglycemia unawareness

• Uncorrected visual impairment

• Deafness

• BMI> 35 kg/m2

Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Device:
• Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)

Locations

Country	Name	City	State
Spain	Parc Tauli University Hospital	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time in target range (3.9-8.0 mmol/l) YSI glucose during the in clinic overnight visit.		During the closed-loop period for each patient: 12 hours